# K262712: Duet™ Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Duet Spine Holdings, LLC
- Decided: Sep 30, 2026 after 61 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K990745 (1999). 116 ancestors in all.
No later device cites it as a predicate yet.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253169: Duet™ Spinal Fixation System, Box Spine, LLC (2026) Summary page 5.

## Indications for use
The Duet ™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (ODD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K262712
Methodology: https://510kreport.com/methodology